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Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Information source: Denver Health and Hospital Authority
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Induced Liver Injury

Intervention: acetaminophen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kennon Heard

Official(s) and/or principal investigator(s):
Kennon Heard, MD, Principal Investigator, Affiliation: Denver Health/Rocky Mountain Poison & Drug Center

Summary

Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.

Clinical Details

Official title: Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts

Secondary outcome: Alanine Aminotransferase (ALT)

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. age 21 years or older 2. provide written informed consent 3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers Exclusion Criteria: 1. History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment 2. Currently taking isoniazid 3. Consumption of any alcoholic beverage during the run-in period 4. A detectable serum acetaminophen at baseline 5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline 6. Platelet count less than 125,000/cc at baseline 7. Positive pregnancy test at baseline (female participants only) 8. Currently adheres to a fasting type diet as determined by self report 9. Currently has anorexia nervosa as determined by self report 10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason 11. Known hypersensitivity to acetaminophen

Locations and Contacts

Denver Health Rocky Mountain Poison and Drug Center, Denver, Colorado 80204, United States
Additional Information

Starting date: August 2007
Last updated: July 10, 2012

Page last updated: August 23, 2015

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